Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Transcriptomic Profile of Adipose Tissue Following n-3 Polyunsaturated Fatty Acid (PUFA) Supplementation

This study has been completed.
Sponsor:
Collaborator:
University College Dublin
Information provided by:
The Adelaide and Meath Hospital
ClinicalTrials.gov Identifier:
NCT01195155
First received: September 2, 2010
Last updated: September 3, 2010
Last verified: July 2008

September 2, 2010
September 3, 2010
December 2007
July 2008   (final data collection date for primary outcome measure)
Gene expression profiling subcutaneous adipose tissue of young women with PCOS following LC n-3 PUFA supplementation versus control [ Time Frame: Following 6 weeks of LC n-3 PUFA supplementation versus 6 weeks olive oil placebo supplementation ] [ Designated as safety issue: No ]
Gene expression profiles were assessed by mircoarray analysis from samples of subcutaneous adipose tissue obtained from subjects following LC n-3 PUFA and placebo supplementation. Single gene changes and pathway analyses will be conducted to assess potential differences between PCOS and control samples.
Same as current
Complete list of historical versions of study NCT01195155 on ClinicalTrials.gov Archive Site
Assessment of biomarkers of hormonal and metabolic health in young women with PCOS following LC n-3 PUFA supplementation versus placebo [ Time Frame: Following 6 weeks of LC n-3 PUFA supplementation versus 6 weeks olive oil placebo supplementation ] [ Designated as safety issue: No ]
Key biomarkers of metabolic health (plasma lipid profile, inflammatory markers and adipokines) and androgenic hormonal profile (testosterone, androstenedione, DHEAS) were assessed by measuring circulating concentrations in plasma.
Same as current
Not Provided
Not Provided
 
Transcriptomic Profile of Adipose Tissue Following n-3 Polyunsaturated Fatty Acid (PUFA) Supplementation
Transcriptomic Profile of Subcutaneous Adipose Tissue of Young Women With PCOS Followin 6 Weeks Supplementation With n-3 PUFA Versus Olive Oil Placebo

Adipose tissue is a central organ involved in mediating metabolic health, and so the investigation of treatments which improve adipose tissue function is warranted. LC n-3 polyunsaturated fatty acid (PUFA) have been shown to exert positive effects on adipose tissue gene expression in previous studies. However this has not been investigated in women with polycystic ovary syndrome (PCOS), a population shown to display a degree of adipose tissue dysfunction. The aim of this study was to determine the impact of LC n-3 PUFA supplementation on gene expression profiles of women with PCOS.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
Dietary Supplement: LC n-3 PUFA (fish oil) Supplement
4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks
Other Names:
  • LC n-3 PUFA (fish oil)
  • Placebo (PL)
  • Wash-out (WO)
  • Active Comparator: LC n-3 PUFA
    Supplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks.
    Intervention: Dietary Supplement: LC n-3 PUFA (fish oil) Supplement
  • Placebo Comparator: Placebo (olive oil) supplement
    4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks.
    Intervention: Dietary Supplement: LC n-3 PUFA (fish oil) Supplement
  • No Intervention: Wash out period
    A 6 week wash out period separated the LC n-3 PUFA and the Placebo (olive oil) arms. During this period the subjects took no supplements. This arm was designed to minimise a cross-over effect.
    Intervention: Dietary Supplement: LC n-3 PUFA (fish oil) Supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
  • Were between the ages of 18 and 40

Exclusion Criteria:

  • Were under 18 years or greater than 40 years old,
  • Were non-Caucasian
  • Were pregnant, lactating or trying to conceive
  • Had a body mass index (BMI) <18kg/m2 or >50kg/m2
  • Had a recent illness or any chronic illness likely to influence results
  • Were taking any medications likely to influence the results including hormonal contraception, antihypertensives, lipid lowering medications, antiplatelet agents, anti-inflammatory agents
  • Were taking nutritional supplements
  • Consumed greater than 2 portions of oily fish per week
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT01195155
DDC-UCD-ATN3
No
Dr James Gibney, The Adelaide and Meath Hospital Incorporating the National Children's Hospital
The Adelaide and Meath Hospital
University College Dublin
Principal Investigator: James Gibney, Dr The Adelaide and Meath Hospital
Principal Investigator: Helen M Roche, Prof University College Dublin
The Adelaide and Meath Hospital
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP